Improving Cognition Through Telehealth Aerobic Exercise and Cognitive Training After a First Schizophrenia Episode

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The participants in the study will receive psychiatric treatment at the UCLA Aftercare Research Program. All participants in this 12-month RCT will receive cognitive training. Half of the patients will also be randomly assigned to the aerobic exercise and strength training condition, and the other half will be randomly assigned to the Healthy Living Group condition. The primary outcome measures are improvement in cognition and level of engagement in the in-group and at-home exercise sessions. Increases in the level of the patient's serum brain-derived neurotropic factor (specifically Mature BDNF) which causes greater brain neuroplasticity and is indicator of engagement in aerobic exercise, will be measured early in the treatment phase in order to confirm engagement of this target. In order to demonstrate the feasibility and portability of this intervention outside of academic research programs, the interventions will be provided via videoconferencing. The proposed study will incorporate additional methods to maximize participation in the exercise condition, including the use of the Moderated Online Social Therapy (MOST) platform to enhance motivation for treatment based on Self-Determination Theory principles, and a bridging group to help the participants generalize gains to everyday functioning. In addition, the exercise group participants will receive personally tailored text reminders to exercise.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• a first episode of a psychotic illness that began within the past three years;

• a diagnosis by DSM-5 of schizophrenia, schizoaffective disorder, or schizophreniform disorder;

• age 18 to 45 years of age;

• sufficient acculturation and fluency in the English language to avoid invalidating research measures; and

• residence likely to be within commuting distance of the UCLA Aftercare Research Program.

Locations
United States
California
UCLA Aftercare Research Program
RECRUITING
Los Angeles
Contact Information
Primary
Rebecca Zornitsky, MSc
RZornitsky@mednet.ucla.edu
(424) 225-1779
Backup
Joseph Ventura, PhD
JVentura@mednet.ucla.edu
(310) 206-3142
Time Frame
Start Date: 2023-05-23
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 100
Treatments
Experimental: Randomization to Combined Cognitive Training and Exercise (CT&E)
The primary interventions for this arm of the protocol are Cognitive Training and Exercise sessions. The Cognitive Training will be conducted in a group format using Zoom videoconferencing, with participants logging into their individual Posit Science cognitive training accounts.~The Aerobic Exercise Program will consist of a physical exercise intervention of 150 minutes/week of moderate aerobic activity, over 4 days, including two group sessions (45 min duration) and two individual sessions (30 min duration in the heart rate zone), for 6 months. After the first 6 months, the group sessions will be once a week with the continuing goal of 150 minutes/week of moderate exercise.
Active_comparator: Cognitive Training and Healthy Living Group (CT&HLG)
The primary interventions for this arm of the protocol are Cognitive Training and the Healthy Living Group. The Cognitive Training will be conducted in a group format using Zoom videoconferencing, with participants logging into their individual Posit Science cognitive training accounts.~The participants in this arm will also participate in a Healthy Living Group, which is a didactic, educational and interactive group that is designed to offer very useful information and discussion of topics that are relevant to a healthy lifestyle. It includes manualized modules devoted to wellness, nutrition, insight, recovery, independent living, social skills, and hobbies. It meets 2 times/week for 6 months and then once a week for the next 6 months.
Related Therapeutic Areas
Sponsors
Leads: University of California, Los Angeles
Collaborators: National Institute of Mental Health (NIMH)

This content was sourced from clinicaltrials.gov